As the international meeting for specialists, we encourage various level people, from beginners to experts, to participate in this annual meeting. Japanese CDM activities are not different from US/EU in processes and technologies. However, there might be major differ-ences in the approaches to policy and strategic issues. Therefore, we should consider what the priorities are, how we can achieve our goals, what we have to succeed to in the next generation, and what improvements we can make to our current situation. That’s the rea-son why we set this year’s main theme.
Objectives of this annual meeting are to improve the quality of trials and to provide ideas for data management activities. This annual meeting will deliver information to attendees about the Japanese clinical data management processes, as well as providing opportuni-ties to meet and network with colleagues in Clinical Data Management.
Featured Topics
Sessions will include standards and quality level, optimized process of data management and clinical development,
b
est practice of data management, technical solutions for data managers, andn
ew tech-nology to affect data management processes.Presentations may include, but are not limited to best practices for data managers, new approach/contribution to clinical development as data managers, ideas to improve data management activities, standards and process optimization of clinical development, regula-tory requirements for data management, computer systems for data management, and other issues for data management.
Who Should Attend
February 4-5, 2010
Tower Hall Funabori, Tokyo, Japan
13th Annual Workshop in Japan for
Clinical Data Management
CDMAA: CDM Amendments Act
The Differences among “I Know,” “I Understand,” and “I Can Make It”
PROGRAM CHAIRPERSON
Atsushi Tsujii
UCB Japan Co., Ltd., Japan
PROGRAM SUB-CHAIRPERSON
Makoto Yokobori
SUXAC Inc., Japan
PROGRAM COMMITTEE
Mineko Fujimoto
Takeda Bio Development Center Limited, Japan
Fumihito Harada
Takeda Pharmaceutical Company Limited, Japan
Ken Katayama
Kowa Company, Ltd., Japan
Mariko Mizumoto
Daiichi Sankyo Co., Ltd., Japan
Kenji Nagaya
Quintiles Transnational Japan K.K., Japan
Hisashi Nomura, PhD
CMIC Co., Ltd., Japan
Yumi Sugiura
Bristol-Myers K.K., Japan
Simultaneous Translation Available
Tabletop Exhibit Opportunity
For information, contact Drug Information Association, LLCMaruei Building 4F, 2-19-9 Iwamoto-cho, Chiyoda-ku, Tokyo 101-0032 Japan Tel: 81-3-5833-8444 Fax: 81-3-5820-8448
email: diajapan@diajapan.org Worldwide Headquarters
Drug Information Association, Inc. 800 Enterprise Road, Suite 200
Horsham, PA 19044, USA Regional Offices
Basel, Switzerland Tokyo, Japan Mumbai, India Beijing, China
•
Clinical data managers•
Clinical research coordinators•
Biostatisticians•
Clinical development professionals•
Information technology professionals•
QC/QA professionalsDAY 1 | THURSDAY, FEBRUARY 4, 2010
9:00-9:30 CDM CHATTING SESSION REGISTRATION 2nd Floor Lobby
9:30-11:30 CDM CHATTING SESSION (CCS) Meeting Rooms (4F)
This session will be conducted in Japanese only.
11:30-13:00 CONFERENCE REGISTRATION 2nd Floor Lobby
13:00-13:15 WELCOME AND OPENING REMARKS Large Hall (5F)
Takatoshi Sato
Director, Drug Information Association LLC, Japan
13:15-13:30 INTRODUCTION Atsushi Tsujii
Director, Biometrics, UCB Japan Co., Ltd., Japan
13:30-15:30 KEYNOTE SESSION SESSIONCHAIRPERSONS
Atsushi Tsujii
Director, Biometrics, UCB Japan Co., Ltd., Japan
Minoru Mizutome
Manager, Data Management, Biometrics, UCB Japan Co., Ltd., Japan
13:30-14:30 KEYNOTE 1
Current Status of Five-year Plan and Approaches
for Global Studies
Takeyuki Sato
Director, Office of Clinical Trial Promotion, Research and Development Division, Ministry of Health, Labour and Welfare (MHLW), Japan
14:30-15:30 KEYNOTE 2
Secondary Use of Data from Electronic Medical
Record
Michio Kimura, MD, PhD
Director and Professor, Department of Medical Informatics, Hamamatsu University School of Medicine, Japan
Unless otherwise disclosed, DIA acknowledges that the statements made by speakers are their own opinion and not necessarily that of the organization they represent, or that of the Drug Information Association.
Speakers and agenda are subject to change without notice.
Recording of any DIA tutorial/workshop information in any type of media, is prohibited without prior written consent from DIA. 15:30-16:00 COFFEE BREAK Zuiun (2F) 16:00-18:00 SESSION 1 Large Hall (5F)
CDM Amendment Act
SESSIONCHAIRPERSONS Fumihito HaradaManager, Clinical Data Management and Biostatistics, Japan Development Center, Pharmaceutical Development Division, Takeda Pharmaceutical Company Limited, Japan
Gaku Ishii
Clinical Data Management and Biostatistics, Japan Development Center, Pharmaceutical Development Division, Takeda
Pharmaceutical Company Limited, Japan
16:00-16:30
How Do We Achieve Early DataBase Freeze in Global Study – From a Role of Monitor
Yosuke Hagiwara
Lead Site Management, Clinical Operations, Wyeth Research, Japan
16:30-17:00
CRC's Expectation Toshiko Ishibashi, PhD
Clinical Research Coordinator, St. Luke's International Hospital, Japan
17:00-17:30
Biomedical Informatics: A New Discipline for a New Pharma
Ronald Fitzmartin, PhD, MBA
Vice President, Informatics and Knowledge, Daiichi Sankyo Pharma Development, Daiichi Sankyo Inc., USA
17:30-18:00
Linked Semantic Data Using Ontologies Eric Karl Neumann, PhD
Director, Clinical Semantics Group, USA
18:15-20:15 RECEPTION Zuiun (2F)
SESSION 2A Large Hall (5F)
Simultaneous translation available
New Approaches for CDM Infrastructure
SESSIONCHAIRPERSONS Makoto Yokobori
President, SUXAC Inc., Japan
Yusuke Morita
Biostatistical Research Co., Ltd., Japan 9:00-9:30
Half-way Up Mount Fuji: Japan Re-emerges as a Force in the Asia-Pacific Drug Development Market
Andy Brock
Director, International Services Development, Phase Forward Europe Ltd., UK
9:30-10:00
EDC as Monitoring Support Tool Thomas Kaponen
Vice President, Project Management, Pharma Consulting Group AB, Sweden
10:00-10:30
The Digital Pen and Paper Technology in Clinical Trials Data Collection
Massimo Raineri
Head of System Development, Biometry, Actelion Pharmaceuticals, Italy
SESSION 2B Togen (2F)
Conducted in Japanese only
Tutorial 1: Basic Statistics for Data Managers
SESSIONCHAIRPERSONS Atsushi Tsujii
Director, Biometrics, UCB Japan Co., Ltd., Japan
Akiko Tanaka
Data Management, Biometrics, UCB Japan Co., Ltd., Japan 9:00-10:30
Tutorial Instructor Hiroshi Ohtsu, MS
Project Assistant Professor, Department of Clinical Trial Data Management, The University of Tokyo Graduate School of Medicine, Japan
9:00-10:30 SESSION 2: PARALLEL TRACKS
SESSION 3A Large Hall (5F)
Simultaneous translation available
CDISC Reality
SESSIONCHAIRPERSONS Kenji Nagaya
Director, Biostatistics and Data Programming, Global Biometrics Services, Japan, Quintiles Transnational Japan K.K., Japan
Hiroshi Azuma
Senior Manager, Data Standard Management Group, Data Science Department, Development Division, Mitsubishi Tanabe Pharma Corporation, Japan
11:00-11:30
Simplifying Trial Data Extraction with CDISC ODM as a Web Service Interface
Aubrey Blazey
Architecture Consultant, Phase Forward Europe Ltd., UK 11:30-12:00
Building an eCRF CDASH Library: A Case Study Ralph Johnson
Senior Clinical Design Consultant, Phase Forward Europe Ltd., UK 12:00-12:30
Implementation and Operation of CDISC ODM-based EDC by UMIN
Takahiro Kiuchi, MD, PhD
Director and Professor, UMIN Center, The University of Tokyo Hospital, Japan
SESSION 3B Togen (2F)
Conducted in Japanese only
Tutorial 2: Quality Management of Clinical Trials
Using EDC Systems
SESSIONCHAIRPERSONS Yumi Sugiura
Clinical Data Manager, Data Management, Clinical Operation, Bristol-Myers K.K., Japan
Makoto Yokobori
President, SUXAC Inc., Japan 11:00-12:30
Tutorial Instructor Koichi Murayama
President and CEO, Consulting Department, eCompliance Ltd., Japan
10:30-11:00 COFFEE BREAK Zuiun (2F)
11:00-12:30 SESSION 3: PARALLEL TRACKS
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DAY 2 | FRIDAY, FEBRUARY 5, 2010
4
SESSION 4A Large Hall (5F)
Simultaneous translation available
EDC with Multinational Studies
SESSIONCHAIRPERSONS Mariko Mizumoto
Associate Manager, Data Management Group, Clinical Data and Biostatistics Department, R&D Division, Daiichi Sankyo Co., Ltd., Japan
Tadashi Yoshimoto
Director, Data Services, Global Biometrics Services, Japan, Quintiles Transnational Japan K.K., Japan
13:30-14:00
Going Global - Collaboration and Integration in CDM Dai Kawaratani
Clinical Data Management Group, Janssen Pharmaceutical K.K., Japan
14:00-14:30
Expanding Internationally Using EDC and Changing the Roles and Responsibilities in CDM
Keisuke Utsumi
Section Manager, eDM Section, Biomedical Data Sciences Department, Development and Medical Affairs Division, GlaxoSmithKline K.K., Japan
14:30-15:00
Enhancement of Communication for eDC Global Study Chiharu Yamaoka
Associate Manager, Global Biometrics Services, Japan, Quintiles Transnational Japan K.K., Japan
SESSION 4B Togen (2F)
Conducted in Japanese only
Tutorial 3: ADR Coding with MedDRA®
SESSIONCHAIRPERSONS Ken Katayama
Chief Clinical Researcher, Clinical Development Department II, Kowa Company Ltd., Japan
13:30-15:00 Tutorial Instructor Yasuo Sakurai
Director, JMO, Pharmaceutical and Medical Device Regulatory Science Society of Japan, Japan
12:30-13:30 LUNCH BREAK Free lunch is available in Zuiun (2F)
13:30-15:00 SESSION 4: PARALLEL TRACKS
SESSION 5A Large Hall (5F)
Simultaneous translation available
Operational Excellence
SESSIONCHAIRPERSONS Mineko Fujimoto
Executive Director, Clinical Data Sciences and Data System, Clinical Development Division, Takeda Bio Development Center Limited, Japan
Reiko Takada
Director, Clinical Data Sciences and Data System, Clinical Development Division, Takeda Bio Development Center Limited, Japan
15:30-16:00
What is Sufficient Quality for Databases? Reza Rostami, MBA, CCDM, RAC
Assistant Director, Quality Assurance and Regulatory Compliance, Duke Clinical Research Institute, USA
SESSION 5B Togen (2F)
Conducted in Japanese only
SESSIONCHAIRPERSONS Hisashi Nomura, PhD Norie Sakaba
Query Center, CDM Division, CRO Company, CMIC Co., Ltd., Japan
Tutorial 4: CDISC Overview
15:30-16:15
TUTORIALINSTRUCTOR Isao Usui, DVM, MS
Manager, Clinical Data and Biostatistics Department, Daiichi Sankyo Co., Ltd., Japan
15:00-15:30 COFFEE BREAK Zuiun (2F)
15:30-17:30 SESSION 5: PARALLEL TRACKS
5
SESSION 5A Large Hall (5F)
Simultaneous translation available
Operational Excellence
continued 16:00-16:30A New Approach to Manage a Clinical Trial Using EDC Metrics Data as Data Manager
Mika Ogasawara
Senior Manager, Data Management, Pfizer Japan Inc., Japan 16:30-17:00
Being Prepared for Regulatory Inspection of EDC System Frances Nolan, MBA
Vice President, Quality Assurance - Regulatory Compliance, Medidata Solutions Worldwide, USA
17:00-17:30
Conformity Audit of Clinical Trials Using EDC Mitsune Yamaguchi, PhD
Deputy Director for GCP Inspection, Office of Conformity Audit, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
SESSION 5B Togen (2F)
Conducted in Japanese only
Tutorial 5: Good Outsourcing Practice
16:15-17:00
TUTORIALINSTRUCTOR Naoki Tomotsugu
Research Associate, Center for Clinical Research, Keio University School of Medicine, Japan
15:30-17:30 SESSION 5: PARALLEL TRACKS continued
17:30 WORKSHOP ADJOURNED
GENERAL INFORMATION
Registration: Registration will start at 11:30 on the first day, and at 8:30 on the second day, on the 2nd floor.
Exhibition: Thursday, February 4, 12:00–20:00 in the room “ZUIUN” on the 2nd floor. Friday, February 5, 9:00–17:30 in the room “ZUIUN” on the 2nd floor.
Reception: Thursday, February 4, 18:15–20:15 in the Exhibition Area on the 2nd floor.
Hotel: There are a limited number of rooms at the Hotel Grand Palace at the reduced rates shown. To reserve a room at the reduced rates for DIA, attendees must use the “Hotel Reservation Request Form” from the Hotel Grand Palace. To download this form, go to http://www.diahome.org/ productfiles/21136/10301_Hotel_Reservation_Form.pdf
Room Rates: Single ¥ 18,050/night / Twin ¥ 21,525/night* Address: 1-1-1 Iidabashi, Chiyoda-ku, Tokyo 102-0072, Japan Telephone: +81-(0)3-3264-3078 / Fax: +81-(0)3-3230-6822 email: toru-ishikawa@grandpalace.co.jp
URL: http://www.grandpalace.co.jp/html/english/index.html
UPCOMING EVENTS
April 13–14, 2010
Tower Hall Funabori, Tokyo, Japan4thAnnual Conference in Japan for Asian New Drug Development Program Chair: Hironobu Saito, PhD, Daiichi Sankyo Co., Ltd., Japan
May 25–26, 2010
Tower Hall Funabori, Tokyo, Japan 1stDIA Cardiac Safety Workshop in JapanProgram Chair: Boaz Mendzelevski, MD, Medifacts International, USA
October 28–29, 2010
Tower Hall Funabori, Tokyo, Japan7thDIA Japan Annual Meeting
Program Chair: Masaru Iwasaki, MD, PhD, GlaxoSmithKline K.K., Japan
March 8–10, 2010
Monaco 22ndAnnual EuroMeetingProgram Chairs: Bruno Flamion, MD, PhD, University of Namur, Belgium and European Medicine Agency, European Union
Kirsten Franzén, Pfizer, Sweden,
June 13–17, 2010
Washington, DC, USA 46thAnnual MeetingProgram Chair: Gaby L. Danan, MD, PhD, sanofi-aventis, France For meeting and tabletop exhibit information, contact Keiko Cambridge
at the Drug Information Association, LLC office in Tokyo by: telephone: +81-3-5833-8444 / fax: +81-3-5820-8448 / email: keiko.cambridge@diajapan.org
If you are interested in obtaining space for a tabletop exhibit, please check the box in the REGISTRATION FEE area on page 11.
REGISTRATION FORM:
Register online or forward to
Drug Information Association, LLC (Japan) Office, Maruei
Building 4F, 2-19-9 Iwamoto-cho, Chiyoda-ku, Tokyo
101-0032 Japan
•
tel +81-3-5833-8444
•
fax +81-3-5820-8448
PAYMENT OPTIONS:
Register online at www.diahome.org or check payment method. BANK TRANSFER TO:
CITIBANK, N.A. Akasaka Branch, Prudential Plaza, Nagatacho 2-13-10, Chiyoda-ku, Tokyo 100-0014, Japan Drug Information Association Ordinary Account Number:
7585284, SWIFT CODE # CITIJPJT.
Your name and company, as well as the above event I.D. number, must be included on the transfer document to ensure payment to your account.
All local and overseas charges incurred for the bank transfer must be borne by payer.
Please include BANK TRANSFER REFERENCE#
________________________________________________________________________
PAYMENT BY CREDIT CARDis available online only – www.diahome.org
13th Annual Workshop in Japan for Clinical Data Management
Event #10301•
February 4-5, 2010•
Tower Hall Funabori, Tokyo, JapanDIA will send participants a confirmation letter within 3 to 5 business days after receipt of their registration.
Registration Fees If DIA cannot verify your membership, you will be charged the nonmember fee. Registration fee includes refreshment breaks and reception (if applicable), and will be accepted by mail, fax, or online.
All fees listed below include the 5% consumption tax.
Member Early-bird Opportunity On or before After
Available on nondiscount member fee only JAN. 15, 2010 JAN. 15, 2010
Member Fee ¥ 44,100 ¥ 50,400
Join DIA now to qualify for the early-bird member fee! MEMBERSHIP www.diahome.org/Membership ¥ 15,750 To qualify for the early-bird discount, registration form and
accompanying payment must be received by the date above. Does not apply to government/academia/nonprofit members.
Nonmember Fee ¥ 78,225 A one-year membership to DIA is available to those paying a NONMEMBER registration fee. If paying a nonmember fee, please indicate if you do, or do not, want membership.
I DO want to be a DIA member I DO NOT want to be a DIA member
Discount Fees MEMBER NONMEMBER
Government (Full-time) ¥ 26,250 ¥ 42,000
Charitable Nonprofit/Academia (Full-time) ¥ 36,750 ¥ 56,175 *If paying a nonmember fee, please check one box above, indicating whether you want membership.
TO RECEIVE AN EXHIBIT APPLICATION, PLEASE CHECK
Last Name
First Name M.I.
Degrees Dr. Mr. Ms. Job Title
Company
Address (As required for postal delivery to your location)
City State Zip/Postal Country
email Required for confirmation
Phone Number Required Fax Number Please check the applicable category: Academia Government Industry
CSO (Contract research/service organization) Student (Call for registration information)
CANCELLATION POLICY
:On or before JANUARY 28, 2010Administrative fee that will be withheld from refund amount: Member or Nonmember =¥21,400
Government/Academia/Nonprofit (Member or Nonmember) = ¥10,700
Cancellations must be in writing and be received by the cancellation date above. Registrants who do not cancel by that date and do not attend will be responsible for the full registration fee paid. Registrants are responsible for cancelling their own hotel and airline reservations. You may transfer your registration to a colleague at any time but membership is not transferable. Please notify DIA of any such substitutions as soon as possible. Substitute registrants will be responsible for nonmember fee, if applicable.
DIA reserves the right to alter the venue, if necessary. If an event is cancelled, DIA is not responsible for any airfare, hotel or other costs incurred by registrants.
TRAVEL AND HOTEL
There are a limited number of rooms at the Hotel Grand Palace at the reduced rates shown below. Room availability at this rate is guaran-teed only until JANUARY 4, 2010 or until the room block is filled. Attendees should make their airline and room reservations as soon as possible.
Single ¥ 18,050/night / Twin ¥ 21,525/night Address: 1-1-1 Iidabashi, Chiyoda-ku, Tokyo 102-0072, Japan Telephone: +81-(0)3-3264-3078 / Fax: +81-(0)3-3230-6822 email: toru-ishikawa@grandpalace.co.jp
URL: http://www.grandpalace.co.jp/english To reserve your room, please contact the Hotel Grand Palace above and mention the DIA Workshop or click here for the Hotel Reservation Form.
TABLETOP EXHIBIT INFORMATION
Attendees may visit the tabletop exhibits during the event and receptions. Contact the Drug Information Association, LLC office in Tokyo.
Telephone +81-(0)3-5833-8444
Fax +81-(0)3-5820-8448
email diajapan@diajapan.org
If you are interested in obtaining space for an exhibit, please check the box in the REGISTRATION FEE area on the left.
2
書面における合意なく、DIAワークショップの情報を録音することは、いかなる形態であっても禁止されています。 発表者および講演タイトルは予告なく変更されることがあります。 特に公表しない限り、本ワークショップにて発表される内容は発表者本人の見解であり、所属する組織、あるいはDIAのものとは限りません。 CDM CHATTING SESSION (CCS) ご挨拶 木村 通男 浜松医科大学 病院情報システムからのデータの二次利用 基調講演 2 佐藤 岳幸 厚生労働省 5ヵ年計画の現状とGlobal Studyへの取組み 基調講演 1 ユーシービージャパン株式会社 ユーシービージャパン株式会社 座長 基調講演 ユーシービージャパン株式会社 はじめに 5階大ホール DIA日本事務所 代表 2階ロビー 受付 日本語のみのセッションとなります 4階会議室 事前申込みが必要となります 2階ロビー CDM Chatting Session受付 9:00-9:30 9:30-11:30 11:30-13:00 13:00-13:15 13:15-13:30 13:30-15:30 13:30-14:30 14:30-15:30 水留 稔 辻井 敦 辻井 敦 佐藤 喬俊1日目 2010年2月4日(木)
CDM AMENDMENT ACT コーヒーブレイク 2階 瑞雲 セッション 1 5階大ホール 座長 武田薬品工業株式会社 武田薬品工業株式会社 −モニターの立場から− グローバル治験における早期のデータ固定のために 臨床試験の実施現場から∼現状と期待∼ 聖路加国際病院 石橋 寿子 ワイス株式会社 萩原 洋輔 バイオメディカルインフォマティックス： CDMの新たなる形 Ronald Fitzmartin Daiichi Sankyo Inc. 存在論を用いたセマンティックデータの連携 Clinical Semantics Group Eric Karl Neumann レセプション 2階 瑞雲 18:15-20:15 17:30-18:00 17:00-17:30 16:30-17:00 16:00-16:30 16:00-18:00 15:30-16:00 石井 岳 原田 史仁s
4
座長 同時通訳あり 座長 日本語のみのセッションとなります 12:30-13:30 ランチブレイク 2階 瑞雲 昼食をご用意しております 13:30-15:00 セッション 4：PARALLEL TRACKS セッション 4A：5階 大ホール 第一三共株式会社 水本 マリ子 クインタイルズ・トランスナショナル・ジャパン株式会社 吉本 正 13:30-14:00 GlobalとのCollaborationを目指して ヤンセンファーマ株式会社 瓦谷 大 14:00-14:30 EDCを用いた国際展開と クリニカルデータマネジメントの変化 グラクソスミスクライン株式会社 内海 啓介 14:30-15:00 eDCグローバル試験におけるコミュニケーションの強化 −治験環境の違いとコミュニケーションの壁を克服するために− クインタイルズ・トランスナショナル・ジャパン株式会社 山岡 千春 セッション 4B：2階 桃源 チュートリアル −利用の実態と標準化の検討− 3：MedDRAによる有害事象コーディングの本質とは 興和株式会社 片山 健 13:30-15:00 財団法人日本公定書協会 櫻井 靖郎 EDC with Multinational StudiesTutorial Instructor 座長 同時通訳あり 座長 日本語のみのセッションとなります 15:00-15:30 コーヒーブレイク 2階 瑞雲 セッション 5：PARALLEL TRACKS 15:30-17:30 セッション 5A：5階 大ホール 武田バイオ開発センター株式会社 藤本 峰子 武田バイオ開発センター株式会社 高田 玲子 15:30-16:00 データベースにとっての十分な品質とは何か？ Duke Clinical Research Institute Reza Rostami セッション 5B：2階 桃源 Operational Excellence 野村 寿 シミック株式会社 坂場 教恵 15:30-16:15 第一三共株式会社 薄井 勲 チュートリアル 4：CDISCの紹介 Tutorial Instructor
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